A prospective multicenter study of direct comparison of feasibility and safety of pulmonary vein isolation using the minimally interrupted apixaban between second-generation cryoballoon and radiofrequency ablation of paroxysmal atrial fibrillation: J-HIT apixaban.

Abstract

BackgroundThe feasibility and safety of pulmonary vein isolation (PVI) using cryoballoon (CB) for paroxysmal atrial fibrillation (PAF) with minimally interrupted apixaban has not fully explored.MethodsIn this multicenter, randomized prospective study, we enrolled patients with PAF undergoing CB or radiofrequency (RF) ablation with interrupted (holding 1 dose) apixaban. The primary composite end point consisted of bleeding events, including pericardial effusion and major bleeding requiring blood transfusion, or thromboembolic events at 4 weeks after ablation; secondary end points included early recurrence of AF and procedural duration.ResultsA total of 250 patients underwent PVI (125 assigned to the RF ablation and 125 assigned to the CB ablation). The primary end point occurred in 1 patient in the CB ablation group (0.8%; 90% confidence interval [CI], 0.04 to 3.70) and 3 patients in the RF group (2.4%, P = .622; risk ratio, 0333; 90% CI, 0.05 to 2.20). All events were pericardial effusion, all of whom recovered after pericardiocentesis. Early recurrence of AF occurred in 4 patients (3.2%) in the RF group and in 6 patients (4.8%) in the CB group (P = .749). The procedural duration was shorter in the CB group than that in the RF group (136.5 ± 39.9 vs 179.5 ± 44.8 min, P < .001).ConclusionCB ablation with minimally interrupted apixaban was feasible and safe in patients with PAF undergoing PVI, which was equivalent to RF ablation.